linezolid injection in sodium chloride Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.

LINEZOLID injection, for intravenous use

Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

9/2023

INDICATIONS AND USAGE

Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4)

Limitations of Use: (1.5)

•
Linezolid is not indicated for the treatment of Gram-negative infections.
•
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration
InfectionPediatric Patients
(Birth through 11 Years of Age)		Adults and Adolescents (12 Years and Older)Duration (days)

Nosocomial pneumonia (1.1)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

10 to 14

Community-acquired pneumonia, including concurrent bacteremia (1.2)

Complicated skin and skin structure infections (1.3)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (1.4)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

14 to 28

•
Pediatric Patients-The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid Injection in a single-dose container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof. (2.1)

DOSAGE FORMS AND STRENGTHS

Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to linezolid or any of the other product components. (4.1)
•
Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)

WARNINGS AND PRECAUTIONS

•
Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. (5.1)
•
Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. (5.2)
•
Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (5.3)
•
A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (5.4)
•
Clostridioides difficile-Associated Diarrhea: Evaluate if diarrhea occurs. (5.5)
•
Potential interactions producing elevation of blood pressure: monitor blood pressure. (5.6)
•
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (5.9)
•
Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): Monitor serum sodium levels regularly in patients at risk of hyponatremia and/or SIADH. (5.10)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, 5.3, 5.6, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

Find linezolid injection in sodium chloride medical information:

Find linezolid injection in sodium chloride medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

linezolid injection in sodium chloride Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.

LINEZOLID injection, for intravenous use

Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

9/2023

INDICATIONS AND USAGE

Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4)

Limitations of Use: (1.5)

•
Linezolid is not indicated for the treatment of Gram-negative infections.
•
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration
InfectionPediatric Patients
(Birth through 11 Years of Age)		Adults and Adolescents (12 Years and Older)Duration (days)

Nosocomial pneumonia (1.1)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

10 to 14

Community-acquired pneumonia, including concurrent bacteremia (1.2)

Complicated skin and skin structure infections (1.3)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (1.4)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

14 to 28

•
Pediatric Patients-The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid Injection in a single-dose container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof. (2.1)

DOSAGE FORMS AND STRENGTHS

Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to linezolid or any of the other product components. (4.1)
•
Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)

WARNINGS AND PRECAUTIONS

•
Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. (5.1)
•
Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. (5.2)
•
Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (5.3)
•
A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (5.4)
•
Clostridioides difficile-Associated Diarrhea: Evaluate if diarrhea occurs. (5.5)
•
Potential interactions producing elevation of blood pressure: monitor blood pressure. (5.6)
•
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (5.9)
•
Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): Monitor serum sodium levels regularly in patients at risk of hyponatremia and/or SIADH. (5.10)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, 5.3, 5.6, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.